Senior Quality Assurance Specialist (Design Development)

Panda International; Bilthoven; Hybrid; EUR 70,000 - 90,000; Full time

Benefits offered by this job

Hybrid working model

Competitive salary

Job summary

Panda International in the Netherlands is seeking a Senior Quality Assurance Specialist to support Design & Development and Change Control. The role is hybrid with about 60% on site in the Utrecht region and involves close collaboration with R&D, Regulatory Affairs, and Operations.

You will drive quality processes across the product lifecycle, lead change control activities, and advise stakeholders on quality best practices. Medical device experience and ISO 13485 knowledge are a plus.

Qualifications

• 5+ years in a Senior QA role within medical devices.
• Experience with Design & Development and Change Control.
• Knowledge of ISO 13485 and regulatory requirements.
• Strong independent-working and stakeholder influencing skills.

Responsibilities

• Act as Quality partner for Design & Development and Change Control.
• Lead Change Control activities and improve related processes.
• Collaborate cross-functionally to ensure lifecycle quality and compliance.
• Drive continuous improvement across quality processes.
• Advise stakeholders on quality best practices and support audits.

Skills

Senior QA experience

Design & Development support

Change Control processes

Regulatory compliance awareness

Quality systems guidance

Stakeholder communication

ISO 13485 knowledge

Job description

Senior Quality Assurance Specialist – Design Development & Change Control

Industry: Medical Devices. Location: Utrecht region, Netherlands. Working: Hybrid - approximately 60% onsite post-onboarding. Set-up: Direct contract with the client (perm) | Initial 12-month contract with long-term opportunity.

About the Opportunity I'm working with an innovative international medical device company that's developing technologies to improve spinal surgery. As they continue to grow, they're looking for an experienced Senior Quality Assurance Specialist to join their team in the Netherlands. This is a great opportunity for someone who enjoys working closely with R&D, supporting new product development, and making sure quality is embedded throughout the design process.

What you'll be doing You'll be the Quality partner for Design & Development and Change Control, working closely with R&D as well as Regulatory Affairs, Operations, and Supply Chain. This is a hands‑on role where you'll help bring structure to quality processes, support business growth, and influence how teams approach quality. Key responsibilities include:

• Supporting Design & Development from a Quality perspective.
• Leading Change Control activities and improving associated processes.
• Working cross-functionally to ensure quality and compliance throughout the product lifecycle.
• Driving continuous improvement across quality processes.
• Advising and supporting stakeholders on quality best practices.
• Supporting audits and regulatory compliance.

What they're looking for

• 5+ years' experience in a Senior QA role.
• Strong experience supporting Design & Development or New Product Development.
• Experience with Change Control and quality process management.
• Comfortable working independently and influencing stakeholders.
• A confident communicator who can explain the "why" behind quality decisions.
• Medical device experience preferred; biotech experience will also be considered.
• Engineering background preferred.
• Knowledge of ISO 13485 and/or FDA Quality System Regulations is a plus.

What's on Offer Join an innovative international medical device organisation developing life-changing technologies. Take ownership of quality activities supporting new product development and organisational growth. Work in a collaborative, cross-functional environment with significant exposure to R&D and business stakeholders. Opportunity to make a tangible impact on quality systems and processes.

• Competitive salary (range: 70-90K including holiday allowance) and benefits package.
• Flexible working options with 32 or 40‑hour contracts possible.
• Hybrid working model with approximately 60% onsite presence.
• Based in the Utrecht region.

Interviews kick off mid-August.